Manager, Regulatory Affairs

Summary

Manage and oversee complex regulatory affairs processes and procedures, and clinical research support and maintenance, for the BCM Breast Oncology clinical research portfolio comprising of over 70 trials. We will be switching over to Advarra eRegulatory Management system to streamline all regulatory process and ensure compliance at a system-wide level. This manager will oversee this project and ensure all current protocols and essential documents are transferred over to the eReg Management system correctly. The project includes assisting and collaborating with different departments within the Dan L Duncan Comprehensive Cancer Center (DLDCCC) to implement e-reg and shared investigator platform within Breast Oncology. Also, in the next 12 months, the number of Breast Oncology investigators will double. With the increase in workload and complexity of trials, the need for an experienced regulatory affairs manager who has a thorough knowledge and understanding of the research regulations (FDA, ICH/GCP) is crucial.

Job Duties

• Prepares initial submissions, renewals and amendments to the FDA, PRMC, and IRB
• Manages relevant federal and international regulatory requirements
• Assists and advises current and incoming Investigators on their compliance with these requirements
• Provides ongoing regulatory training and guidance to research staff, also clinical staff and faculty as needed
• Assists with developing, implementing and monitoring research protocols, procedures and processes
• Develops, implements and maintains departmental policies, guidelines, and standard operating procedures (SOPs) to ensure clinical trials are conducted in a manner that meet departmental, institutional and federal requirements
• Manages all aspects of clinical trials from study start-up to study close out, and serve as the primary regulatory affairs contact for study staff, investigators, sponsors, and the IRB concerning all Breast Oncology trials
• Recruits, hires, trains, supervises and oversees the daily and weekly activities of all direct reports
• Manages workload for research team; responsible for work results of all direct reports: responsible for annual performance reviews, goal setting and promotions within the team

Minimum Qualifications

• Bachelor's degree.
• Four years of relevant experience.

Preferred Qualifications

• Four years of regulatory experience
• Two years of management experience
• Oncology experience

Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

13898

CA; SN